书目名称 | Integrated Safety and Risk Assessment for Medical Devices and Combination Products | 编辑 | Shayne C. Gad | 视频video | | 概述 | Identify and verify the most appropriate available data.As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest.As the dura | 图书封面 |  | 描述 | .While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation..Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex..A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant(yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understan | 出版日期 | Book 2019 | 关键词 | medical device toxicology; medical devices and combination products safety; device materials; biocompat | 版次 | 1 | doi | https://doi.org/10.1007/978-3-030-35241-7 | isbn_softcover | 978-3-030-35243-1 | isbn_ebook | 978-3-030-35241-7 | copyright | Springer Nature Switzerland AG 2019 |
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